Catalog Number

-

Brand Name

NA

Version/Model Number

S1001-2100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Public Device Record Key

5973f6b7-5ca5-4a0b-8b63-bb33f4219ff6

Public Version Date

March 24, 2021

Public Version Number

1

DI Record Publish Date

March 16, 2021

Package DI Number

04713616091343

Quantity per Package

10

Contains DI Package

04713616091336

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-